Minimally invasive systems for and methods of preparing and fusing a sacroiliac joint during interventional procedures

ABSTRACT

A system for performing a minimally invasive interventional fusion procedure on a sacroiliac joint of a patient. The system may include a disposable sterile packed implant and kit including access, bone cutting, accessory and extraction instruments.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. applicationSer. No. 16/822,997 filed Mar. 18, 2020, which application is acontinuation of U.S. application Ser. No. 16/133,605 filed Sep. 17,2018, now U.S. Pat. No. 10,603,055, which application claims priorityunder 35 U.S.C. § 119 to U.S. Provisional Patent Application Nos.62/559,386 filed Sep. 15, 2017; 62/608,476 filed Dec. 20, 2017;62/609,095 filed Dec. 21, 2017; 62/632,635 filed Feb. 20, 2018; and62/640,026 filed Mar. 8, 2018. All of the aforementioned applicationsare hereby incorporated by reference in their entireties into thepresent application.

The present application also claims the benefit of and priority to U.S.Provisional Application Nos. 62/938,344 filed Nov. 21, 2019 and63/134,971 filed Jan. 8, 2021.

The present application incorporates by reference the following patentapplications in their entireties: U.S. patent application Ser. No.16/544,193 filed Aug. 19, 2019; U.S. patent application Ser. No.16/455,308 filed on Jun. 27, 2019; U.S. patent application Ser. No.16/431,301 filed on Jun. 4, 2019; U.S. provisional patent applicationSer. No. 62/854,041 filed May 29, 2019; U.S. patent application Ser. No.16/282,114 filed Feb. 21, 2019; U.S. patent application Ser. No.16/133,605 filed Sep. 18, 2018 which claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application Nos. 62/559,386 filed Sep.15, 2017; 62/608,476 filed Dec. 20, 2017; 62/609,095 filed Dec. 21,2017; 62/632,635 filed Feb. 20, 2018; and 62/640,026 filed Mar. 8, 2018.All of the aforementioned U.S. patent applications are herebyincorporated by reference in their entireties into the presentapplication.

TECHNICAL FIELD

Aspects of the present disclosure relate to medical apparatus andmethods. More specifically, the present disclosure relates to devicesand methods for preparing and fusing a sacroiliac joint for fusion.

BACKGROUND

The sacroiliac joint is the joint between the sacrum and the ilium ofthe pelvis, which are joined by ligaments. In humans, the sacrumsupports the spine and is supported in turn by an ilium on each side.The sacroiliac joint is a synovial joint with articular cartilage andirregular elevations and depressions that produce interlocking of thetwo bones.

Pain associated with the sacroiliac joint can be caused by traumaticfracture dislocation of the pelvis, degenerative arthritis, sacroiliitisan inflammation or degenerative condition of the sacroiliac joint,osteitis condensans ilii, or other degenerative conditions of thesacroiliac joint. Currently, sacroiliac joint fusion is most commonlyadvocated as a surgical treatment for these conditions. Fusion of thesacroiliac joint can be accomplished by several different conventionalmethods. However, while each of these methods has been utilized forfixation and fusion of the sacroiliac joint over the past severaldecades, substantial problems with respect to the fixation and fusion ofthe sacroiliac joint remain unresolved.

A significant problem with certain conventional methods for fixation andfusion of the sacroiliac joint may be that the surgeon has to make asubstantial incision in the skin and tissues for direct access to thesacroiliac joint involved. These invasive approaches allow thesacroiliac joint to be seen and touched directly by the surgeon. Oftenreferred to as an “open surgery”, these procedures have the attendantdisadvantages of requiring general anesthesia and can involve increasedoperative time, hospitalization, pain, and recovery time due to theextensive soft tissue damage resulting from the open surgery.

A danger to open surgery using an anterior approach can be damage to theL5 nerve root, which lies approximately two centimeters medial to thesacroiliac joint or damage to the major blood vessels. Additionally andas seen in FIG. 1, which depicts a conventional fusion procedure(immobilization of the articular surfaces of the sacroiliac joint inrelation to one another) on a sacroiliac joint 1, one or more screws orimplants 2 are implanted transversely across the articular surfaces 3and through the sacrum 4 and the ilium bones 5. That is, the joint 1 isimmobilized by placement of a fusion device 2 transverse to or across aplane defined by articular surfaces 3 of the sacroiliac joint space.

Use of trans-sacroiliac and S1 pedicle-iliac bone implants can alsoinvolve the risk of damage to the lumbosacral neurovascular elements.Damage to the lumbosacral neurovascular elements as well as delayedunion or non-union of the sacroiliac joint by use of these proceduresmay require revision surgery to remove all or a portion of the implantsor repeat surgery as to these complications.

Another significant problem with conventional procedures utilizingminimally invasive small opening procedures can be that the proceduresare technically difficult, requiring biplanar fluoroscopy of thearticular surfaces of the sacroiliac joint and extensive surgicaltraining and experience. Despite the level of surgical training andexperience, there is a substantial incidence of damage to thelumbosacral neurovascular elements. Additionally, sacral anomalies canfurther lead to mal-placement of implants leading to damage ofsurrounding structures. Additionally, these procedures are oftenperformed without fusion of the sacroiliac joint, which does not removethe degenerative joint surface and thereby does not address thedegenerative condition of the sacroiliac joint, which may lead tocontinued or recurrent sacroiliac joint pain.

Another significant problem with conventional procedures can be theutilization of multiple trans-sacroiliac elongate implants, which do notinclude a threaded surface. This approach requires the creation oftrans-sacroiliac bores in the pelvis and nearby sacral foramen, whichcan be of relatively large dimension and which are subsequently broachedwith instruments, which can result in bone being impacted into thepelvis and neuroforamen.

The creation of the trans-sacroiliac bores and subsequent broaching ofthe bores requires a guide pin, which may be inadvertently advanced intothe pelvis or sacral foramen, resulting in damage to other structures.Additionally, producing the trans-sacroiliac bores, broaching, orplacement of the elongate implants may result in damage to thelumbosacral neurovascular elements, as above discussed. Additionally,there may be no actual fusion of the articular portion of the sacroiliacjoint, which may result in continued or recurrent pain requiringadditional surgery.

Another substantial problem with conventional procedures can be thatplacement of posterior extra-articular distracting fusion implants andbone grafts may be inadequate with respect to removal of the articularsurface or preparation of cortical bone, the implant structure andfixation of the sacroiliac joint. The conventional procedures may notremove sufficient amounts of the articular surfaces or cortical surfacesof the sacroiliac joint to relieve pain in the sacroiliac joint. Theconventional implant structures may have insufficient or avoidengagement with the articular surfaces or cortical bone of thesacroiliac joint for adequate fixation or fusion. The failure tosufficiently stabilize and fuse the sacroiliac joint with theconventional implant structures and methods may result in a failure torelieve the condition of sacroiliac joint being treated. Additionally,conventional methods of driving apart a sacrum and ilium may lead tomal-alignment of the sacroiliac joint and increased pain.

Improvements to sacroiliac joint fusion involve systems and methods fornon-transverse delivery of an implant into the sacroiliac joint aredescribed in U.S. patent application Ser. No. 12/998,712, filed May 23,2011 entitled SACROILIAC JOINT FIXATION FUSION SYSTEM; Ser. No.13/236,411, filed Sep. 19, 2011 entitled SYSTEMS FOR AND METHODS OFFUSING A SACROILIAC JOINT; and Ser. No. 13/475,695, filed May 18, 2012,entitled SYSTEMS FOR AND METHODS OF FUSING A SACROILIAC JOINT; and Ser.No. 13/945,053, filed Jul. 18, 2013, entitled SYSTEMS FOR AND METHODS OFFUSING A SACROILIAC JOINT; and Ser. No. 13/946,790, filed Jul. 19, 2013,entitled SYSTEMS FOR AND METHODS OF FUSING A SACROILIAC JOINT; and Ser.No. 14/216,975, filed Mar. 17, 2014, entitled SYSTEMS AND METHODS FORFUSING A SACROILIAC JOINT AND ANCHORING AN ORTHOPEDIC APPLIANCE; andSer. No. 14/447,612, filed Jul. 31, 2014, entitled SYSTEMS FOR ANDMETHODS OF FUSING A SACROILIAC JOINT. All of application Ser. Nos.12/998,712, 13/236,411, 13/475,695, 13/945,053, 13/946,790, 14/216,975,and 14/447,612 are herein incorporated by reference in their entirety.In certain instances, it may be desirable to prepare the surfaces of thesacroiliac joint prior to implantation of the fusion device, e.g., theintra-articular or extra-articular surfaces. While surgical preparationtools may exist for procedures in other areas of the body, tools forpreparing the sacroiliac joint for fusion are lacking. Thus, the systemsand methods discussed herein address the challenges in preparing thesacroiliac joint for fixation and fusion.

SUMMARY

One implementation of the present disclosure may take the form of asurgical preparation tool for preparing a sacroiliac joint having asacrum and an ilium for a surgical procedure.

Aspects of the present disclosure may include a system for performing afusion procedure on a sacroiliac joint defined between a sacrum and anilium. In certain instances, the system may include a working cannulathat may include a proximal end, a distal end, a tubular body extendingbetween the proximal and distal ends, a cannula passageway definedwithin the tubular body and having a cannula axis extending therethrough. In certain aspects, the tubular body may have a generallycircular cross section perpendicular to the cannula axis. In otheraspects, the tubular body may have a generally ovular cross sectionperpendicular to the cannula axis. In yet further aspects, the tubularbody may have a generally slot shaped or even rectangular cross sectionperpendicular to the cannula axis. Irrigation, suction, lighting,electrocautery, bone engaging features, visual or radiographic markers,or electrophysiologic monitoring electrodes and electrical insulationmay be incorporated into the working cannula or other tools or implantsof the system.

In certain instances, the tubular body may include an inner surface thatdefines the cannula passageway, the inner surface may receive a portionof a guide rail assembly including a pair of guide rails extendinginward from opposite sides of the inner surface and along the cannulaaxis. Another portion of the guide rail assembly including a ringstructure may be seated at the proximal end of the working cannula. Theguide rail assembly may further include a fastening portion coupled withthe ring structure and configured to receive a fastener in order to locka position and or orientation and or arrangement between the guide railassembly and the working cannula. The fastening portion may be connectedwith the ring structure such that the fastening portion may engage thetubular body and, for example, may be positioned up against an outersurface of the tubular body when the ring structure is seated at theproximal end of the working cannula. In certain instances, the guiderail assembly may be configured to be rotatable in relationship to theworking cannula with an infinite resolution of rotational position. Inother aspects the guide rail assembly may be configured to be rotatablein relationship to the working cannula with a finite resolution ofindexable rotational positions.

In certain instances, the system may include a joint finder that mayinclude a proximal end, a distal end, a tubular body extending betweenthe proximal and distal ends, a joint finder passageway defined withinthe tubular body and having a joint finder axis extending there through,the passageway configured to receive a needle (e.g., a 20, 18 or 16gauge needle with the hub removed), a head at the distal end, a radiallaser marking near the proximal end and a handle quick connect interfaceat the proximal end. The head may have a tapered shape and may include aheight perpendicular to the joint finder axis which is substantiallygreater than a diameter of the outer diameter of the tubular bodyconfigured to act as a stop to prevent over drilling or over broachingduring certain steps of the procedure.

In certain instances, the system may include a depth gauge configured togo over the joint finder and further configured to seat within theworking cannula congruently in order to maintain concentricity with thetubular body of the working cannular and still further configured toseat up against the proximal end of the working cannula in order toregister correctly with the working cannula length.

In certain instances, the system may include a cannulated drill bitconfigured to be placed over the joint finder. The cannulated drill bitmay include a pattern of radial grooves configured to couple with anadjustable depth stop. In certain aspects, the cannulated drill bit maybe only partially cannulated with a plugged proximal end which isconfigured to abut the proximal end of the joint finder in order toprevent over drilling. In certain aspects, a drill sleeve is providedhaving an outer diameter which is configured to seat closely within theworking cannula to assist in maintaining concentricity with the desireddrilling trajectory and having an inner diameter which is sized close tothe outer diameter of the drill bit in order to constrain the trajectoryof the drill bit during use.

In certain instances, the system may include a pilot broach and afinishing broach. Each broach may include a cannulated tubular bodyconfigured to be placed over the joint finder. The cannulated tubularbody may include a pattern of radial grooves configured to couple withfurther adjustable depth stops. In certain aspects, the cannulatedtubular body may be only partially cannulated with a plugged proximalend which is configured to abut the proximal end of the joint finder inorder to prevent over broaching.

In certain instances, the guide rail assembly may be installed withinthe working cannula prior to broaching, while the broach is at leastpartially received in the working cannula, while the broach is in thebone defining the sacroiliac joint, or after broaching. The guide railassembly may be configured to guide a broach or series of broaches up toand into the bones defining the sacroiliac joint by adjustably (ornon-adjustably) constraining the trajectory and orientation of thebroach relative to the sacroiliac joint of the patient. Following jointpreparation (e.g., broaching) the guide rail assembly may be maintainedin the same position as was used for the joint preparation in order toaccurately guide an implant in to the implant receiving space created bythe previous drilling and broaching steps. According to particularaspects, the pair of guide rails may have a shape, size and arrangementwhich generally matches an outer profile of the implant body. Forexample, the shape, size and arrangement of the pair of guide rails maybe configured to constrain and guide an X-shaped implant having fourgaps defined in between four arms of the implant by having a guide railouter surface which closely approximates the shape, size and arrangementof the gap or more than one gap (e.g., opposing gaps) thereby preventinggross rotation of the implant along the implant axis.

In certain instances, the system further may include an inserter toolhaving a distal end with an implant-shape-matching portion configured todeliver the implant into the sacroiliac joint. Theimplant-shape-matching portion may also be guided by the pair of rails.According to certain aspects, the inserter tool may couple with theimplant using a collet mechanism selectively actuated between a lockedor unlocked condition. According to yet other aspects, the inserter toolmay couple with the implant using a pair of opposing spring arms.

In certain instances, the system further may include the joint implant.

In certain instances, the joint implant may include an implant bodyincluding at least one planar member extending a length between aproximal end and a distal end, and an opening extending through theimplant body.

In certain instances, the implant body defines X-shaped cross-section.

In certain instances, the inner surface of the tubular body of theworking cannula may be keyed to a cross-sectional shape of a jointimplant to permit passage of the joint implant therethrough.

In certain instances, the system further may include the joint implant.

In certain instances, the tubular body may include an inner surface thatdefines the cannula passageway, the inner surface defining anon-circular perimeter.

Aspects of the present disclosure may include a method of performing afusion procedure on a sacroiliac joint defined between a sacrum and anilium, where the sacroiliac joint may include an articular region, andthe ilium may include a posterior superior iliac spine (PSIS) and aposterior inferior iliac spine (PIIS). In certain instances, the methodmay include: positioning a distal end of a working cannula up to thejoint line inferior to the PSIS while aligning the cannula axis to begenerally located between the sacrum and the ilium via a posterioraccess.

In certain instances, the method further may include inserting a distalportion of a cutting tool through the cannula passageway and into thesacroiliac joint so as to prepare the sacrum and the ilium for insertionof the joint implant.

In certain instances, the cutting tool may include at least one toolfrom a group may include a rasp, a drill bit, a chisel, a broach, apaddle shaver, a curette, a bur, a saw blade, a mill bit, a router bit,a reciprocating saw, a sagittal saw, a box osteotome and an ultrasonicoscillating cutter. Additionally, the cutting tool (or as a separatetool used in conjunction therewith) may further include a surgicalaspirator and may include an irrigation supply and suction supply toprovide continuous irrigation and active suction in order to maintain asurgical site clear of liquids and debris which may also provide a clearfield of view allowing for enhanced visualization.

In certain instances, the method further may include removing bonematerial from the PSIS in order to place the bone material within thebone window of the implant and or adjacent the implant prior to or afterplacement of the implant at the sacroiliac joint.

In certain instances, the method further may include implanting the bonematerial into at least one or both of the joint implant and thesacroiliac joint using a tamp. A bone packing block may fixture theimplant to hold the implant and to plug up at least one or more openingsof the bone window when inserting bone material into the implant.

In certain instances, the joint implant may be inserted at leastpartially into the articular region of the sacroiliac joint via aposterior access region defined between the PSIS and the PIIS.

According to particular embodiments, the working cannula may have atransverse attachment point for a handle or other structure (e.g. toallow attachment to a surgical table either directly or via an (e.g.,FISSO brand) articulating arm surgical tool holder).

In certain instances, the system may comprise a lance configure to goover the needle such that once a distal tip of the lance touches thepatient's skin, upon applying sufficient force, a cutting tip and edgesof the lance cut through the skin, through the soft tissue and up to thebones defining the sacroiliac joint. The lance guided by the needleprovides an accurate and reliable means to create an appropriately sizedand positioned incision in order to deliver the joint finder, a seriesof dilators and, at about the maximum incision diameter provided by thelance, the working cannula.

While multiple embodiments are disclosed, still other embodiments of thepresent disclosure will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the disclosure. As will be realized, thevarious embodiments of the present disclosure are capable ofmodifications in various aspects, all without departing from the spiritand scope of the present disclosure. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1-119 illustrate various tools and steps according to particularembodiments of systems and methods for preparing and treating asacroiliac joint as can be understood by the description herein and alsoin the patent applications incorporated by reference.

DETAILED DESCRIPTION

The present application incorporates by reference the following patentapplications in their entireties: Ser. No. 12/998,712 filed on May 23,2011; Ser. No. 13/135,381 filed on Jul. 1, 2011; Ser. No. 14/127,119filed on Dec. 17, 2013; Ser. No. 13/236,411 filed on Sep. 19, 2011; Ser.No. 13/475,695 filed on May 18, 2012; Ser. No. 13/945,053 filed on Jul.18, 2013; Ser. No. 13/946,790 filed on Jul. 19, 2013; Ser. No.14/344,876 filed on Mar. 13, 2014; Ser. No. 14/216,975 filed on Mar. 17,2014; Ser. No. 14/681,882 filed on Apr. 8, 2015; Ser. No. 15/061,524filed on Mar. 4, 2016; Ser. No. 15/178,244 filed on Jun. 9, 2016; Ser.No. 15/178,291 filed on Jun. 9, 2016; Ser. No. 15/216,472 filed on Jul.21, 2016; Ser. No. 15/664,608 filed on Jul. 31, 2017; Ser. No.15/664,862 filed on Jul. 31, 2017; Ser. No. 14/514,221 filed on Oct. 14,2014, now U.S. Pat. No. 9,826,986; Ser. No. 14/723,384 filed on May 27,2015; Ser. No. 14/567,956 filed on Dec. 14, 2014; Ser. No. 14/447,612filed Jul. 31, 2014; Ser. No. 14/413,318 filed Jan. 7, 2015; Ser. No.15/418,633 filed on Jan. 27, 2017; 62/608,476 filed Dec. 20, 2017;62/609,095 filed Dec. 21, 2017; 62/632,635 filed Feb. 20, 2018;62/640,026 filed Mar. 8, 2018; Ser. No. 16/133,605 filed Sep. 17, 2018;U.S. patent application Ser. No. 16/544,193 filed Aug. 19, 2019; U.S.patent application Ser. No. 16/455,308 filed on Jun. 27, 2019; U.S.patent application Ser. No. 16/431,301 filed on Jun. 4, 2019; U.S.provisional patent application Ser. No. 62/854,041 filed May 29, 2019;and U.S. patent application Ser. No. 16/282,114 filed Feb. 21, 2019.

Implementations of the present disclosure involve a system for preparinga sacroiliac joint for fusion. In particular, the system may include apreparation tool for removing articular cartilage from the sacroiliacjoint space, abrading of the articular surfaces to enhance bony fusion,and removal of portions of the cortical, subchondral or cancellous bonefor implantation of a fusion device. The preparation tool may include ananchoring arm that is configured to direct an anchoring element fortransverse delivery through the sacroiliac joint space. The anchor maybe delivered into the joint space before, during, or after the jointspace is prepared for implant delivery. Alternatively, an implant maynot be delivered into the joint and instead, e.g., bone paste or slurrymay be introduced into the prepared sacroiliac joint before or afteranchor placement. And, the anchor may be delivered cranial, caudal, infront of, behind, above, below, next to, up to, near, adjacent, awayfrom, through, or in-line with the eventual placement of the implant.The preparation tool is configured to quickly, accurately and reliablyprepare the joint space for insertion of an implant.

Implementations of the present disclosure may further includeradiographic tools adapted to confirm placement of the joint implant andanchors prior to their implantation. According to particularembodiments, a radiographic tool may include a radiographic implanttemplate (not shown) positioned near, up to or within the patient's bodyin order to approximate the orientation, location, size, configurationand implantation trajectory of the implant and employed either: i) priorto the incision of the patient's skin, ii) prior to the preparation ofthe sacroiliac joint, iii) prior to the creation of the central portionof the implant receiving space, iv) prior to the creation ofsubstantially the entire implant receiving space, v) after placement ofa pin or other guidance instrument (e.g., joint finder) into thesacroiliac joint, vi) after the preparation of the sacroiliac joint,vii) after the creation of the central portion of the implant receivingspace, viii) after the creation of substantially the entire implantreceiving space; for example, the implant template may include a shapecomprising a cross section of the implant and may further comprise anoverlapping pattern of implant sizes or configurations in order todetermine, e.g., desired implant size or configuration in relation tothe sacroiliac joint an surrounding anatomy. As an example, such toolsmay be used after removing articular cartilage but prior to abrading orotherwise removing the cortical, subchondral or cancellous bone of thejoint. The tools may be used before making cuts for keels or othermembers extending beyond the portion of the implant at the plane of thejoint and after preparing the plane of the sacroiliac joint in order tocreate at least a portion of the implant receiving space, which, e.g.,may approximate the shape and size of the portion of the implant to besituated therein and, e.g., may be configured to accommodate acylindrical body, a rectangular body. In other aspects the implantreceiving space may be fully prepared before employing the radiographictools. The radiographic tools generally include radiopaque markers orstructures that are viewable using a radiography system, such as afluoroscope or X-ray. By aligning the radiopaque markers/structures withanatomical features of the patient or other radiopaque elements of thetools, parameters for implanting the anchors (such as anchorconfiguration and size, location, orientation, and depth) may bedetermined and confirmed prior to the substantial tissue removalrequired for implanting the joint implant and/or the anchor.

The drawing sheets illustrate certain tools and methods of use fortreating a sacroiliac joint.

The cutting tool may be configured as a dual serrated edge blade poweredby an oscillating tool. For example, an ultrasonically powered systemmay be employed and as a non-limiting example, may include an ultrasonicoscillating tool which is configured to couple longitudinal vibrationwith torsional oscillation such as the SONOPET Ultrasonic Aspiratoravailable from STRYKER.

The cutting tool may be constrained and guided by a guide block.

The foregoing merely illustrates the principles of the embodimentsdescribed herein. Various modifications and alterations to the describedembodiments will be apparent to those skilled in the art in view of theteachings herein. It will thus be appreciated that those skilled in theart will be able to devise numerous systems, arrangements and methodswhich, although not explicitly shown or described herein, embody theprinciples of the embodiments described herein and are thus within thespirit and scope of the present disclosure. From the above descriptionand drawings, it will be understood by those of ordinary skill in theart that the particular embodiments shown and described are for purposesof illustrations only and are not intended to limit the scope of thepresent disclosure. References to details of particular embodiments arenot intended to limit the scope of the disclosure.

What is claimed is:
 1. A system for performing a fusion procedure on asacroiliac joint defined between a sacrum and an ilium, the systemcomprising: a working cannula comprising a proximal end, a distal end, atubular body extending between the proximal and distal ends, a cannulapassageway defined within the tubular body and having a cannula axisextending therethrough; a guide rail assembly comprising a pair of guiderails extending generally parallel to each other from a ring structure,wherein the ring structure is configured to engage the proximal end ofthe working cannula and the pair of guide rails is configured to fitwithin the cannula passageway; an implant having a body extendingbetween a distal end and a proximal end; and wherein the pair of guiderails are arranged, configured and sized to guide the implant along animplantation trajectory while maintaining a predetermined implantorientation.